medical HIGH RISK Updated 2025-08-06

Draeger, Inc. recalls HME TwinStar HEPA Plus Filter. Bidirectionally breathing sys

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Recalled Product

HME TwinStar HEPA Plus Filter. Bidirectionally breathing system filter.

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Hazard / Issue

Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model No. MP05801; UDI: 04048675665823; All Lots.

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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